MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MULTILUMEN/PSI SET; CATHETER,INTRAVASCULAR,THERAP

Catalog Number SI-11142

Device Problems Crack (1135); Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/31/2024

Event Type  malfunction  

Event Description

It was reported "the md found a leak in the part connecting the needle syringe.So the md opend up the new kit to finish the procedure." no medical intervention required.The patient's current condition is reported as "fine".No patient harm or injury.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).The complaint of syringe/needle connection not secure was able to be confirmed by a complaint investigation of the returned sample.The customer returned one 18ga introducer needle attached to a 10ml syringe for analysis.Signs of use were observed on the returned components.Visual analysis of the introducer needle revealed a crack in the needle hub.Microscopic analysis confirmed the damage.The returned 10ml syringe was not included in the bill of materials (bom) for the reported finished good.The only syringe within the kit is an arrow raulerson syringe (ars) and it was not returned for analysis.Visual analysis could not be performed on the ars as it was not returned for analysis.The instructions for use (ifu) provided with this kit warns the user, "some disinfectants used at device insertion site contain solvents which can weaken the device material.Alcohol, acetone, and polyethylene glycol can weaken the structure of polyurethane materials." further investigation of this issue was performed under capa previously implemented by the teleflex quality systems.Based on the capa investigation, the root cause of this complaint was design related.Teleflex has identified that this needle hub material is susceptible to cracking when placed under stress (i.E.Pressed onto a tapered luer fitting, sideloaded as the clinician attempts to locate a vessel, etc.) in the presence of liquid alcohol-based disinfectants.The needle hub involved with this complaint was manufactured prior to the capa implementation date.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported "the md found a leak in the part connecting the needle syringe.So the md opened up the new kit to finish the procedure." no medical intervention required.The patient's current condition is reported as "fine".No patient harm or injury.

• Brand Name: ARROW MULTILUMEN/PSI SET
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18779215
• MDR Text Key: 336232117
• Report Number: 3006425876-2024-00186
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K002507
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SI-11142
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/05/2202
• Initial Date FDA Received: 02/26/2024
• Supplement Dates Manufacturer Received: 03/15/2024
• Supplement Dates FDA Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED